MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-12 for ACCESS VITAMIN B12 ASSAY 33000 manufactured by Beckman Coulter.
[4579998]
The customer reported erroneous vitamin b12 results, for multiple patients, involving the access vitamin b12 assay used in conjunction with the unicel dxi 800 access immunoassay system. The customer noted quality control (qc) failed and reanalyzed the last five patients' samples, on the same instrument, and noted discrepant results. The erroneous results were released out of the laboratory, however, there was no report of patient injury or change in patient treatment associated with this event. The customer stated amended reports were issued to the hospital. The customer noted all the erroneous results were generated from a single reagent pack and indicated controls, on a new reagent pack, were acceptable. The patients' samples were frozen serum aliquots. The samples were centrifuged at 5,000 rpm (rotations per minute) for six minutes, at room temperature. No sample integrity issues were reported. A beckman coulter field service engineer (fse) was dispatched to assess the instrument.
Patient Sequence No: 1, Text Type: D, B5
[11911187]
There is no indication that the access vitamin b12 device was returned for evaluation. The field service engineer (fse) verified the instrument was performing within established specifications. No system issues were noted. The fse identified and noted the erroneous results were generated from a single reagent pack. Service activity performed was verified to meet the specified requirements per established procedures. The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation. In conclusion, the likely cause of the event is attributed to the vitamin b12 reagent pack. A definitive cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2014-00519 |
| MDR Report Key | 3930726 |
| Report Source | 05,06 |
| Date Received | 2014-07-12 |
| Date of Report | 2014-06-15 |
| Date of Event | 2014-06-15 |
| Date Mfgr Received | 2014-06-15 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-07-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS VITAMIN B12 ASSAY |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2014-07-12 |
| Model Number | NA |
| Catalog Number | 33000 |
| Lot Number | 336925 |
| ID Number | NA |
| Device Expiration Date | 2015-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-12 |